Training course on Introducing pharmacovigilance into HIV/AIDS programmes Pretoria, South Africa, September 1-10,2004

1. Training course on Introducing pharmacovigilance into HIV/AIDS programmesPretoria, South Africa,September 1-10,2004

2. Training course on Introducing pharmacovigilance into HIV/AIDS programmes ANTIRETROVIRALS USED IN KENYA Presentation by Dorine Kagai and Wilfred Oguta

3. STRUCTURE FOR PROVISION OF ARV DRUGS NATIONAL AIDS CONTROL COUNCIL(NACC) MINISTRY OF HEALTH OTHER MINISTRIES OTHERS Ministerial Aids Committees Pharmacy &Poisons Board Drug regulation Market surveillance Kenya Medical Supply Agency(KEMSA0 National Aids and STI Control Programme Procurement and distribution (NASCOP) of medicines Training Healthcare Workers Procurement and provision Guidelines and policy on … Implementation of ART in hospitals Assessment and supervision

4. Training course on Introducing pharmacovigilance into HIV/AIDS programmes Role of NACC • Oversees and coordinates all the HIV/AIDS Committees • Communication to the public. (VCT .Prevention. Advertisement) • Resource mobilization NASCOP is involved in: • Training HEALTHCARE workers • Procurement and provision • What to procure? Specifications. • What quantities? • This is done in collaboration with Ministerial Tender Committee (MTC) and Kenya Medical Supplies Agency (KEMSA) .Directorate of Public Procurements (DPP) is also involved. • Guidelines and Policy • Implementation of antiretroviral therapy programmes in hospitals • Supervision and assessment

5. Training course on Introducing pharmacovigilance into HIV/AIDS programmes • Storage and Distribution of antiretroviral is done by KEMSA. • NASCOP assists with coordination of distribution i.e. • Whom to give and how much • Draws the list of allocations

6. Training course on Introducing pharmacovigilance into HIV/AIDS programmes • Initial installation of the drugs is done by NASCOP i.e. • Training of healthcare workers on tracking of patients, dosage regimen and any changes as may be necessary. Guidelines followed. • Drugs are given as patient packs for purposes of promoting patient compliance and should not be broken • Logistics data collection and reporting. Patients, numbers, gender, age, regimen used, opportunistic infections etc. Monthly summary and request forms very useful.

7. Supervision and assessment • Quarterly logistics monitoring, evaluation and supervision conducted by NASCOP / KEMSA to check stock status conditions including; • Adequacy of stocks • Out of stock situations • Damages/Losses • Expiry dates • storage conditions -security -temperatures -accessibility • Accuracy of logistics data submitted.

8. Training course on Introducing pharmacovigilance into HIV/AIDS programmes DRUGS USED Already available in public sector • Stavudine (d4T) • Lamivudine (3TC) • Nevirapine (NVP) • Efavirenz (EFV) To be available in the next few months • Zidovudine (AZT) • Didanosine (ddI) • Lopinavir/ritonavir (Kaletra) Lpv/r • Nelfinavir (NFV)

9. Training course on Introducing pharmacovigilance into HIV/AIDS programmes Drugs used… According to the National Antiretroviral Therapy guidelines first line and second line regimen are given as follows: 1st Line d4T+ 3TC + NVP or D4t +3TC +EFV for patients on Rifampicin, those who react to NVP, or those previously on EFV 2nd Line ddI + AZT + Lpv/r or ddI + AZT + NLF for those who react to Lpv/r or are intolerant.

10. Training course on Introducing pharmacovigilance into HIV/AIDS programmes Prevention of Mother to Child Transmission (PMTCT) Nevirapine 200mg to the mother at onset of labour and 2mg/kg body wt to the baby 72 hrs from birth OR AZT 300mg OD from 36 weeks gestation, then 300 q3hrs at onset of labour OR AZT 100mg 5 times daily from 14 weeks gestation, and to the baby 2 mg /kg body weight qid for six weeks OR Mother started on HAART if <20 weeks gestation and the baby given either NVP 2mg/kg body wight within 72 hours of delivery or AZT 2mg/kg body weight for 6 weeks.

11. Training course on Introducing pharmacovigilance into HIV/AIDS programmes For Post Exposure Prophylaxis (PEP.) 3TC 150mg bd + AZT 300mg bd. Pediatric Regime 1st line. AZT + 3TC + NVP OR d4T + 3TC + NVP. 2nd line. AZT + ddI + LPV/r (If patient was on AZT as 1st line.) OR d4T + ddI + LPV/r (If patient was on d4T as 1st line.)

12. Training course on Introducing pharmacovigilance into HIV/AIDS programmes MONITORING OF DRUGS • The drug regulatory authority (Pharmacy and Poisons Board-PPB) is in charge of Post-Marketing Surveillance and monitoring of drugs. • The National Quality Control Laboratory (NQCL) is mandated to do quality analysis of all drugs. • However, adverse drug reactions/events monitoring and reporting has not been developed.

13. MONITORING OF DRUGS…. • Some specific programmes e.g. Malaria Control Programme perform random sampling and quality analysis of relevant drugs in the market • Every batch of antiretroviral received at KEMSA is subjected to quality checks (specifically assay, dissolution and lately friability tests) • Discussions with NQCL and PPB to develop a post-marketing surveillance programme for ARVs are ongoing.